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New treatment option for Advanced Solid Tumor
Official title A Study of RC118 Plus Toripalimab / RC148 in Patients with Locally Advanced Unresectable or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06038396
What this study is testing
What is RC118?
RC118 is an investigational medicine, being studied as a potential treatment for advanced solid tumor.
Also referred to as RC118 for injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open, multi-center, dose escalation and expansion phase I/II study. The Phase I study will explore the tolerability and safety of RC118 in combination with Toripalimab for the treatment of patients with Claudin 18.2-positive, locally advanced unresectable or metastatic malignant solid tumors, and to establish the maximum tolerated dose (MTD) and the recommended dose in phase II clinical trials (RP2D); The Phase II study will evaluate the efficacy and safety of RC118 in combination with Toripalimab or RC148 in patients with locally advanced or metastatic Gastric cancer/Gastro-esophageal junction cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Be able to participate in the study voluntarily and willing to provide written informed consent.
- male or female 18 ≤ age ≤ 75 years old.
- Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- The expected survival ≥12 weeks.
- Enrollment of people with locally advanced or metastatic gastric adenocarcinoma/adenocarcinoma of the gastroesophageal junction who have a...
You likely can't join if
- Pregnant women, breastfeeding women or women with a positive blood pregnancy test result during the screening period (non-fertile women do not need...
- people with active hepatitis B (HBsAg positivity and HBV DNA titre higher than the normal upper limit), active hepatitis C (HCVAb positivity and HCV...
- people with a history of other acquired or congenital immunodeficiency diseases, or who have undergone organ or bone marrow transplantation.
- people who have previously received monoclonal antibody, double antibody targeting drugs, ADC, CAR-T and other therapeutic drugs targeting Claudin...
- Have vaccinated within 4 weeks prior to the first dose or plan to receive any live vaccine during the study.
- people are atallergic to the ingredients or excipients of the experimental drug.
See the full eligibility criteria
Who can join
- Be able to participate in the study voluntarily and willing to provide written informed consent.
- male or female 18 ≤ age ≤ 75 years old.
- Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- The expected survival ≥12 weeks.
- Enrollment of people with locally advanced or metastatic gastric adenocarcinoma/adenocarcinoma of the gastroesophageal junction who have a histologically confirmed diagnosis and have failed standard therapy.
- people who received ≤2 prior systemic therapies.
- people agree to provide tumor tissue specimens for Claudin 18.2 and PD-L1 expression levels during the screening period. Samples should have moderate to high expression of Claudin 18.2 by membrane staining.
- According to the RECIST v1.1, there is at least one measurable target lesion.
- Sufficient heart, bone marrow, liver and kidney functions.
- Fertile male or female people must agree to take effective contraceptive measures during the study period and for 6 months after the end of the last dose, such as double-barrier contraceptive methods(eg. condoms), oral...
What rules you out
- Pregnant women, breastfeeding women or women with a positive blood pregnancy test result during the screening period (non-fertile women do not need to undergo a pregnancy test, such as women with a previous hysterectomy...
- people with active hepatitis B (HBsAg positivity and HBV DNA titre higher than the normal upper limit), active hepatitis C (HCVAb positivity and HCV RNA titre higher than the normal upper limit), and positive human...
- people with a history of other acquired or congenital immunodeficiency diseases, or who have undergone organ or bone marrow transplantation.
- people who have previously received monoclonal antibody, double antibody targeting drugs, ADC, CAR-T and other therapeutic drugs targeting Claudin 18.2 or other ADCs with MMAE payload; or have participated in clinical...
- Have vaccinated within 4 weeks prior to the first dose or plan to receive any live vaccine during the study.
- people are atallergic to the ingredients or excipients of the experimental drug.
- people who have received anti-tumor therapy (chemotherapy, radiotherapy, immunotherapy, or targeted therapy) within 4 weeks or less than 5 half-lives of the experimental drug prior to the start of the first dose; or who...
- The toxicity of previous anti-tumor therapy has not returned to the level 0 or 1 as defined by NCI-CTCAE v5.0 (except for alopecia, pigmentation and other long-term toxicity ≤2 that cannot be recovered which was defined...
- The clinical symptoms of pleural effusion, abdominal effusion, or pericardial effusion that requires drainage.
- Active infection within 2 weeks prior to the first dose that requires systemic anti-inflammatory therapy.
- Complicating other diseases that seriously endanger the safety of the people or affect the completion of the study, such as peptic ulcer, intestinal obstruction, intestinal paralysis, interstitial pneumonia, pulmonary...
- The tumor lesion has a bleeding tendency or has received blood transfusion treatment within 4 weeks prior to the first dose.
- During the screening period, QTc interval \>450 ms(male), QTc interval \>470ms(female); previous family or personal history of long/short QT interval syndrome; A history of ventricular arrhythmia deemed clinically...
- Previous myocardial infarction (within 6 months prior to the first dose), severe or unstable angina, coronary or peripheral artery bypass grafting, heart failure grade 3\~4 defined by New York Heart Association (NYHA)...
- Experienced an arterial/venous thromboembolic event within 6 months prior to the study.
- Active autoimmune disease that requires systemic treatment within 2 years prior to the study. Patients with vitiligo, psoriasis, alopecia or Grave's disease that not requires systemic treatment, hypothyroidism that only...
- people with brain metastases and/or carcinomatous meningitis who have previously received related treatment may be considered for inclusion if their disease has been stable for at least 3 months, no imaging evidence of...
- Other malignant tumor within 5 years prior to the signature of informed consent.
- Major surgery or treatment therapy was performed within 4 weeks prior to the first dose and did not fully recovered (except tumor biopsy and puncture).
- For Phase II people:
- Received an immune checkpoint inhibitor (anti-PD-1/PD-L1/CTLA-4 antibody) or other immune checkpoint inhibitor therapy within 28 days prior to the first treatment with the test drug;
- Prior concurrent receipt of antitumor agents targeting VEGF/VEGFR and PD-1/PD-L1;
- Experienced permanent discontinuation of immunotherapy due to toxicity of immune checkpoint inhibitor therapy prior to receiving administration of study drug;
- Currently receiving anticoagulant medications (except for people on prophylactic doses of heparin).
- A history of uncontrollable mental illness or people currently experiencing such conditions.
- people with poor compliance who are expected to be unable to complete the study.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Xiamen, Fujian, China
- Wuwei, Gansu, China
- Meizhou, Guangdong, China
- Harbin, Heilongjiang, China
- Nanyang, Henan, China
- Xinyang, Henan, China
- Zhengzhou, Henan, China
- Xuzhou, Jiangsu, China
- Bengbu, Shandong, China
- Jinan, Shandong, China
- Changzhi, Shanxi, China
- Chengdu, Sichuan, China
- Neijiang, Sichuan, China
- Hangzhou, Zhejiang, China
- Wenzhou, Zhejiang, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Xiamen, Fujian, China; Wuwei, Gansu, China; Meizhou, Guangdong, China; Harbin, Heilongjiang, China; Nanyang, Henan, China and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.